Ophthalmic lens with retinal vascularization monitoring system

ABSTRACT

The present invention relates to an ophthalmic device with a retinal vascularization monitoring system and associated methods. In some embodiments, the ophthalmic device can be a contact lens with a retinal vascularization monitoring system that can be used to monitor temporal changes of a pulsating vessel forming part of the retinal vascularization. Further, the retinal vascularization monitoring system may include elements for delivering a signal, including an audible and/or visual message, to the user that can be useful for identifying abnormal conditions such as a cardiac failure without delay. The audible and/or visual messages can be signals communicated to the user using one or both of the ophthalmic device and a wireless device in communication with the ophthalmic device.

FIELD OF THE INVENTION

The present invention relates to an energized ophthalmic device with aretinal vascularization monitoring system, and more specifically, thesystem used for the early detection of abnormal cardiac relatedconditions of a user.

BACKGROUND OF THE INVENTION

Traditionally, an ophthalmic device, such as a contact lens, anintraocular lens, or a punctal plug, included a biocompatible devicewith a corrective, cosmetic, or therapeutic quality. A contact lens, forexample, may provide one or more of vision correcting functionality,cosmetic enhancement, and therapeutic effects. Each function is providedby a physical characteristic of the lens. A design incorporating arefractive quality into a lens may provide a vision corrective function.A pigment incorporated into the lens may provide a cosmetic enhancement.An active agent incorporated into a lens may provide a therapeuticfunctionality. Such physical characteristics are accomplished withoutthe lens entering into an energized state. An ophthalmic device hastraditionally been a passive device.

Novel ophthalmic devices based on energized ophthalmic inserts haverecently been described. These devices may use the energization functionto power active optical components. For example, a wearable lens mayincorporate a lens assembly having an electronically adjustable focus toaugment or enhance performance of the eye, and/or embeddablemicroelectronic devices that can be useful for the diagnosis andtreatment of various health conditions or diseases.

Retinal vascular imaging has recently been explored as a non-invasivealternative tool to analyze the role and pathophysiology of themicrovasculature. For instance, research has demonstrated that acorrelation exists between conditions of the retinal vascularization,forming part of the microvasculature, and cardiovascular disease andhypertension. Typically, screening for the diagnosis and monitoring ofcardiac conditions is done by an electrocardiogram (also known as an ECGor EKG). An electrocardiogram can be used to measure the rate andregularity of heartbeats, the size and position of the chambers, thepresence of any damage to the heart, and the effects of drugs or devicesused to regulate the heart by analysis of the electrical activity of theheart over a period of time, as detected by electrodes attached to thesurface of the skin and recorded by a device external to the body.However, getting an electrocardiogram for many patients can not only behighly burdensome but is also not recommended for individuals absentadditional symptoms or for patients who are at low risk. Moreover, forthose at higher risk electrocardiogram screening results can beinconclusive.

The microvasculature includes vessels between 100 μm and 300 μm makingthe study and analysis of these vessels difficult in part due to theirsize. In addition, until recently the methods and procedures used toinvestigate the microvasculature have all been invasive and requirehighly specialized tools and settings. More recently however, withadvances in photographic image techniques and computer-assisted imageanalysis techniques, alternative techniques that utilize non-invasivelarge complex cameras have been explored. These non-invasive techniquesin turn can allow physicians and researchers to image and study theretinal vascularization of a patient.

Although these new non-invasive techniques can be useful for the studyand understanding of microvascular changes, they continue to requirespecialized equipment and settings for the imaging of the retinalvascularization of a patient. Consequently, the timing and changes thatcan be observed are interrupted by large periods of time (i.e. timebetween appointments), and therefore less than optimal. In order toovercome the aforementioned limitations and improve the accuracy of theretinal vascularization analysis, novel and reliable systems/methodsthat can monitor changes in the retinal vascularization of a patientinnocuously and without significant delay are desired.

SUMMARY OF THE INVENTION

The foregoing needs are met, to a great extent, by the presentinvention, wherein in one aspect an energized ophthalmic deviceincorporating a retinal vascularization monitoring system is disclosed.The retinal vascularization monitoring system can include amicro-piezoelectric element with a feedback circuit that can be used forthe ultrasound imaging of at least a portion of the retinalmicrovascularization. The image captured can be analyzed to measure andquantify changes without significant delay. The changes can be used tosignal, to the patient or physician, or record abnormal cardiac pulse ofa patient. In some embodiments, alternatively or in addition to theimaging aspect of the retinal vascularization monitoring system, amicrosensor can be used to capture signals arising from a person'scardiac pulse.

According to some aspects of the disclosure, an energized ophthalmicdevice with a retinal vascularization monitoring system is disclosed.The ophthalmic device including: a media insert comprising a front curvearcuate surface and a back curve arcuate surface, wherein the frontcurve arcuate surface and the back curve arcuate surface form a cavitycapable of containing an energy source dimensioned to conform to an areawithin the cavity, wherein the energy source is in electrical connectionand capable of energizing a micro-piezoelectric element with anelectronic feedback circuit and a controller, the controller comprisinga computer processor in digital communication with a digital mediastorage device and wherein the digital media storage device storessoftware code; a transmitter in logical communication with the processorand also in logical communication with a communication network, whereinthe software is executable upon demand and operative with the processorto: receive data descriptive of at least one identified portion of apulsating vessel forming part of a retinal vascularization of an eye;cause the micro-piezoelectric element to output a signal towards the atleast one identified portion of the pulsating vessel; receive data fromthe electronic feedback circuit descriptive of the change of theoutputted signal outputted towards the at least one identified portionof the pulsating vessel; image the at least one identified portion ofthe pulsating vessel using the data received from the electronicfeedback circuit; and monitor changes of the retinal vascularization bycomparing said at least one identified portion imaged with a previousimage over time.

In additional aspects of the disclosure, an associated method ofmonitoring the retinal vascularization of a patient's eye is disclosed.The method including: identifying at least one location of a pulsatingvessel in the retinal vascularization of an eye; providing an ophthalmicdevice with a retinal vascularization monitoring system comprising anenergy source in electrical connection and capable of energizing amicro-piezoelectric element with an electronic feedback circuit and acontroller comprising a computer processor, a digital media storagedevice, a transmitter in logical communication with the processor andalso in logical communication with a communication network; outputting asignal towards the at least one pulsating location identified using themicro-piezoelectric element with the electronic feedback circuit;receiving, using the feedback circuit, a return signal from theoutputted signal; imaging the at least one pulsating location using thechange in the outputted signal and the return signal; and monitoringchanges of the retinal vascularization by comparing said at least oneidentified portion images with a previous image of the same said atleast one identified portion over time.

In yet additional aspects of the disclosure, the method of monitoringthe retinal vascularization of a patient's eye can alternativelyinclude: identifying locations forming part of the retinalvascularization of the patient's eye including at least a portion of apulsating vessel; providing an ophthalmic device with a retinalvascularization monitoring system comprising an energy source inelectrical connection and capable of energizing a micro-piezoelectricelement with an electronic feedback circuit and a controller comprisinga computer processor, a digital media storage device, a transmitter inlogical communication with the processor and also in logicalcommunication with a communication network; detecting a change in acontrolled signal outputted towards the at least said portion of thepulsating vessel identified; imaging the at least said portion of theretinal vascularization of the patient's eye using the detected changein said controlled signal; and recording the changes in the at leastsaid portion of the retinal vascularization between a series of imagesover time.

There has thus been outlined, rather broadly, certain aspects of theinvention in order that the detailed description thereof herein may bebetter understood, and in order that the present contribution to the artmay be better appreciated. There are, of course, additional aspects ofthe invention that will be described below and which will form thesubject matter of the claims appended hereto.

In this respect, before explaining at least one aspect of the inventionin detail, it is to be understood that the invention is not limited inits application to the details of construction and to the arrangementsof the components set forth in the following description or illustratedin the drawings. The invention is capable of aspects in addition tothose described and of being practiced and carried out in various ways.Also, it is to be understood that the phraseology and terminologyemployed herein, as well as the abstract, are for the purpose ofdescription and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the invention. It is important, therefore,that the claims be regarded as including such equivalent constructionsinsofar as they do not depart from the spirit and scope of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following, more particular description of exemplaryembodiments of the invention, as illustrated in the accompanyingdrawings.

FIG. 1A is a diagrammatic cross section representation of a firstexemplary energized ophthalmic device comprising both optics and aretinal vascularization monitoring system in accordance with aspects ofthe present disclosure;

FIG. 1B is an enlarged portion of the cross section depicted in FIG. 1Ashowing aspects of the retinal vascularization monitoring system inaccordance with aspects of the present disclosure;

FIG. 2A is a diagrammatic representation of the top view of a mediainsert that may be included as part of an ophthalmic device comprisingboth optics and the retinal vascularization monitoring system inaccordance with aspects of the present disclosure;

FIG. 2B is a diagrammatic representation of an isometric view of anophthalmic device including the media insert depicted in FIG. 2Acomprising the retinal vascularization monitoring system in accordancewith aspects of the present disclosure;

FIG. 3 is a diagrammatic sectioned isometric view of another exemplaryenergized ophthalmic device comprising both optics and the retinalvascularization monitoring system in accordance with aspects of thepresent disclosure;

FIG. 4 is a schematic diagram of an exemplary cross section of a stackeddie integrated components implementing the retinal vascularizationmonitoring system in accordance with aspects of the present disclosure;

FIG. 5 is a schematic diagram of a processor that may be used toimplement some aspects of the present disclosure;

FIG. 6A illustrates a region of the retinal vascularization of an eyethat can be utilized according to aspects of the present disclosure;

FIG. 6B illustrates the region of the retinal vascularization of an eyeof FIG. 6A with a digital overlay that can be used for the analysis ofthe retinal vascularization according to aspects of the presentdisclosure;

FIG. 7 illustrates a side cross section representation of a patient'seye with an energized ophthalmic device according to aspects of thepresent disclosure; and

FIG. 8 illustrates method steps that can be implemented by the systemaccording to aspects of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The disclosure will now be described with reference to the drawingfigures, in which like reference numerals refer to like partsthroughout.

Various aspects of the ophthalmic device disclosed may be illustrated bydescribing components that are coupled, sealed, attached, and/or joinedtogether. As used herein, the terms “coupled,” “sealed,” “attached,”and/or “joined” are used to indicate either a direct connection betweentwo components or, where appropriate, an indirect connection to oneanother through intervening or intermediate components. In contrast,when a component is referred to as being “directly coupled,” “directlysealed,” “directly attached,” and/or “directly joined” to anothercomponent, there are no intervening elements present.

Relative terms such as “lower” or “bottom” and “upper” or “top” may beused herein to describe one element's relationship to another elementillustrated in the drawings. It will be understood that relative termsare intended to encompass different orientations in addition to theorientation depicted in the drawings. By way of example, if aspects ofan exemplary ophthalmic device shown in the drawings are turned over,elements described as being on the “bottom” side of the other elementswould then be oriented on the “top” side of the other elements. The term“bottom” can therefore encompass both an orientation of “bottom” and“top” depending on the particular orientation of the apparatus.

Various aspects of an ophthalmic device with a retinal vascularizationmonitoring system may be illustrated with reference to one or moreexemplary embodiments. As used herein, the term “exemplary” means“serving as an example, instance, or illustration,” and should notnecessarily be construed as preferred or advantageous over otherembodiments disclosed herein.

GLOSSARY

In this description and claims directed to the disclosed invention,various terms may be used for which the following definitions willapply:

Energized: as used herein refers to the state of being able to supplyelectrical current to or to have electrical energy stored within.

Energy: as used herein refers to the capacity of a physical system to dowork. Many uses within this disclosure may relate to the said capacitybeing able to perform electrical actions in doing work.

Energy Source: as used herein refers to a device or layer that iscapable of supplying energy or placing a logical or electrical device inan energized state.

Energy Harvester: as used herein refers to a device capable ofextracting energy from the environment and converting it to electricalenergy.

Functionalized: as used herein refers to making a layer or device ableto perform a function including for example, energization, activation,or control.

Ophthalmic Device: as used herein refers to any device that resides inor on the eye. These devices may provide optical correction, may becosmetic, or may provide functionality unrelated to vision. For example,the term ophthalmic lens may refer to a contact lens, intraocular lens,overlay lens, ocular insert, optical insert, or other similar devicethrough which vision can be corrected or modified, detection andtreatment of a condition or through which eye physiology is cosmeticallyenhanced (e.g. iris color) without impeding vision. In addition to oralternatively, the ophthalmic lens may provide non-optic functions, forexample, monitoring glucose levels, cardiac rhythm, recording ameasurement, delivering sound signals, delivering visual signals, and/oradministrating medicine. In some embodiments, the preferred lenses ofthe invention are soft contact lenses are made from silicone elastomersor hydrogels, which include, for example, silicone hydrogels, andfluorohydrogels.

Lithium Ion Cell: as used herein refers to an electrochemical cell whereLithium ions move through the cell to generate electrical energy. Thiselectrochemical cell, typically called a battery, may be reenergized orrecharged in its typical forms.

Media Insert: as used herein refers to an insert that that can form partof an energized ophthalmic device. The energization elements andcircuitry may be incorporated in the media insert. The media insert candefine the primary purpose of the energized ophthalmic device. Forexample, in embodiments where the energized ophthalmic device allows theuser to adjust the optic power, the media insert may includeenergization elements that control a liquid meniscus portion in theoptical zone of the ophthalmic device. Alternatively, a media insert maybe annular so that the optical zone is void of material. In suchembodiments, the energized function of the lens may not be optic qualitybut may be, for example, monitoring glucose, sound/light delivery,and/or administering medicine.

Micro-Acoustic Element(s): as used herein can refer to a micro acousticelectromechanical system and/or related components that can be used toconduct audible frequencies from the orb of the eye to the inner earthrough the bones in the skull. In some embodiments, the micro-acousticelements can include, for example, a micro-electromechanical (MEMS)piezoelectric acoustic transducer and/or a condenser acoustic device,energized by an energy source contained in the ophthalmic device.

Operating Mode: as used herein refers to a high current draw state wherethe current over a circuit allows the device to perform its primaryenergized function.

Optical Zone: as used herein refers to an area of an ophthalmic devicethrough which a wearer of the ophthalmic device sees.

Power: as used herein refers to work done or energy transferred per unitof time.

Reenergize or Recharge: as used herein refers to restoring to a statewith higher capacity to do work. Many uses within this invention mayrelate to restoring a device to the capability to flow electricalcurrent at a certain rate and for a certain reestablished period.

Reference: as use herein refers to a circuit which produces an, ideally,fixed and stable voltage or current output suitable for use in othercircuits. A reference may be derived from a bandgap, may be compensatedfor temperature, supply, and process variation, and may be tailoredspecifically to a particular application-specific integrated circuit(ASIC).

Reset Function: as used herein refers to a self-triggering algorithmicmechanism to set a circuit to a specific predetermined state, including,for example, logic state or an energization state. A reset function mayinclude, for example, a power-on reset circuit, which may work inconjunction with the switching mechanism to ensure proper bring-up ofthe chip, both on initial connection to the power source and on wakeupfrom storage mode.

Retinal Vascularization Monitoring System: as used herein refers anenergized micro-piezoelectric element with a feedback circuit that canbe configured to be included in an ophthalmic device and enable thevisualization and detection a pulsating vessel forming part of theretinal microvascularization. In some embodiments, the retinalvascularization monitoring system may focus on imaging one or morepre-identified specific areas of the retina in which changes of thevessels can be observed due to cardiac rhythm or an abnormal condition.In addition or alternatively, the retinal vascularization monitoringsystem can include a microsensor that can be used to capture/hearfrequency signals arising from a person's cardiac pulse.

Sleep Mode or Standby Mode: as used herein refers to a low current drawstate of an energized device after the switching mechanism has beenclosed that allows for energy conservation when operating mode is notrequired.

Stacked: as used herein means to place at least two component layers inproximity to each other such that at least a portion of one surface ofone of the layers contacts a first surface of a second layer. In someembodiments, a film, whether for adhesion or other functions may residebetween the two layers that are in contact with each other through saidfilm.

Stacked Integrated Component Devices or SIC Devices: as used hereinrefers to the products of packaging technologies that assemble thinlayers of substrates that may contain electrical and electromechanicaldevices into operative-integrated devices by means of stacking at leasta portion of each layer upon each other. The layers may comprisecomponent devices of various types, materials, shapes, and sizes.Furthermore, the layers may be made of various device productiontechnologies to fit and assume various contours.

Storage Mode: as used herein refers to a state of a system comprisingelectronic components where a power source is supplying or is requiredto supply a minimal designed load current. This term is notinterchangeable with standby mode.

Substrate Insert: as used herein refers to a formable or rigid substratecapable of supporting an energy source within an ophthalmic device. Insome embodiments, the substrate insert also supports one or morefunctional electrical or electromechanical components.

Switching Mechanism: as used herein refers to a component integratedwith the circuit providing various levels of resistance that may beresponsive to an outside stimulus, which is independent of theophthalmic device.

Recent developments in ophthalmic devices including, for example,contact lenses, have occurred enabling functionalized ophthalmic devicesthat can be energized. The energized ophthalmic device can comprise thenecessary elements to correct and/or enhance the vision of users usingembedded micro-electronics. Additional functionality usingmicro-electronics can include, for example, variable vision correction,tear fluid analysis, audio, and/or visual feedback to the user. Inaddition to having the capability of providing vision correctionfunctionality, the present disclosure provides for an ophthalmic devicethat includes a retinal vascularization monitoring system. The retinalvascularization monitoring system can include an energizedmicro-piezoelectric element with a feedback circuit. In someembodiments, the ophthalmic device can be in wireless communication withone or more wireless device(s) and transmit signal data that can be usedfor the determination of an abnormal condition and a correlated causeand/or the cardiac rhythm of a user. The wireless device(s) can include,for example, a smart phone device, a tablet, a personal computer, a FOB,a drug pump, an MP3 player, a PDA, and the like.

In some aspects of the present disclosure, an ophthalmic device caninclude a retinal vascularization monitoring system to enable thevisualization and detection of pulses of vessels forming part of theretinal microvascularization. In some embodiments, the retinalvascularization monitoring system may focus on imaging one or morespecific areas of the retina in which greater changes of the vessels canbe observed due to cardiac rhythm or an abnormal pre-identifiedcondition. In addition or alternatively, the retinal vascularizationmonitoring system can include a microsensor that can be used tocapture/hear frequency signals arising from a person's cardiac pulse.

Referring now to FIG. 1A, a diagrammatic cross section representation ofa first exemplary energized ophthalmic device 100 comprising both opticsand a retinal vascularization monitoring system is depicted. Accordingto some aspects of the present disclosure, the ophthalmic device 100 ofthe present disclosure may be a contact lens resting on the anteriorsurface of a patent's eye 110. The contact lens may be a soft hydrogellens and can include a silicone containing component. A“silicone-containing component” is one that contains at least one[—Si—O—] unit in a monomer, macromer or prepolymer. Preferably, thetotal Si and attached O are present in the silicone-containing componentin an amount greater than about 20 weight percent, and more preferablygreater than 30 weight percent of the total molecular weight of thesilicone-containing component. Useful silicone-containing componentspreferably comprise polymerizable functional groups such as acrylate,methacrylate, acrylamide, methacrylamide, vinyl, N-vinyl lactam,N-vinylamide, and styryl functional groups.

Embedded by the hydrogel portion partially or entirely, or in someembodiments placed onto the hydrogel portion, can be a functionalizedmedia insert 150. The media insert 150 can be used to encapsulatefunctionalized elements 105, including electronic and electromechanicalelements, and in some embodiments one or more energy source (in section140 magnified in FIG. 1B). In some embodiments, the functionalizedelements 105 can preferably be located outside of the optical zone 175,such that the device does not interfere with the patient's sight.Functionalized elements 105 may be powered through an external means,energy harvesters, and/or energization elements contained in theophthalmic device 100. For example, in some embodiments the power may bereceived using an antenna receiving RF signals that is in communicationwith the electronic elements 105.

Referring now to FIG. 1B, an enlarged portion 140 of the cross sectiondepicted in FIG. 1A showing aspects of the retinal vascularizationmonitoring system is depicted. In particular, the enlarged portion 140illustrates a hydrogel portion 116 of the ophthalmic device 100 restingon ocular fluid 112 on the anterior surface of the eye 110. Ocular fluid112 can include any one, or a combination of: tear fluid, aqueoushumour, vitreous humour, and other interstitial fluids located in theeye. The hydrogel portion 116 may encapsulate the media insert 150 whichin some embodiments can include energization elements 118, such as abattery and a load, along with components of the retinal vascularizationmonitoring system 126.

The retinal vascularization monitoring system 126 can include a wirelesscommunication element 120, such as a RF antenna in connection with acontroller 122. The controller 122 can be used to control apiezoelectric transducer 130, a pick up 135, and an electronic feedbackcircuit including an amplifier 124 and a band-pass filter 126 which canall be powered through the energization elements 118 contained withinthe media insert 150. The piezoelectric transducer 130 and the pick-up135 can resonate a signal and measure the change in the return signal toimage one or more portions of the retinal vascularization. Thepiezo-electric transducer may be placed in contact with the retina. Uponthe application of electrical pulses, ultrasound pulses emanate from itfor them to echo back to the surface and converted back to electricalpulses that can then be processed by the system and formed into animage. The images can be produced by surfaces or boundaries between twodifferent types of tissues, such as the vessels forming part of theretina and the vitreous humour of the eye. Because the vitreous humouris a relatively homogenous gelatinous mass with insignificant amounts ofsolid matter, an identified portion of the retinal vascularization maybe imaged by changing the focal depth from the transducer. The focaldepth can be adjusted by changing the time delay between the electricalpulses. By sending ultrasound pulses at different depths around anidentified pulsating vessel, the imaging definition required to identifysmall temporal changes in width and displacement can be achieved.

Referring now to FIG. 2A, a diagrammatic representation of the top viewof a media insert 200 that may be included as part of another exemplaryophthalmic device 100 comprising both optics and the retinalvascularization monitoring system 205 is depicted. In particular, a topview of an exemplary media insert 200 for an energized ophthalmic device250 (shown in FIG. 2B) that can include retinal vascularizationmonitoring system 205 is illustrated. The media insert 200 may comprisean optical zone 220 that may or may not be functional to provide visioncorrection. Where the energized function of the ophthalmic device isunrelated to vision, the optic zone 220 of the media insert 200 may bevoid of material. In some embodiments, the media insert 200 may includea portion not in the optical zone 220 comprising a substrate 215incorporated with energization elements 210 and electronic components205 which include retinal vascularization monitoring system elements.

In some embodiments, a power source 210, which may be, for example, abattery, and a load 205, which may be, for example, a semiconductor die,may be attached to the substrate 215. Conductive traces 225 and 230 mayelectrically interconnect the electronic components 205 and theenergization elements 210. In some embodiments, the media insert 200 canbe fully encapsulated to protect and contain the energization elements210, traces 225 and 230, and electronic components 205. In someembodiments, the encapsulating material may be semi-permeable, forexample, to prevent specific substances, such as water, from enteringthe media insert 200 and to allow specific substances, such as ambientgasses, fluid samples, and/or the byproducts of reactions withinenergization elements 210, to penetrate and/or escape from the mediainsert 200.

Referring now to FIG. 2B, a diagrammatic representation of an isometricview of an ophthalmic device including the media insert depicted in FIG.2A comprising both optics and the retinal vascularization monitoringsystem is depicted. The media insert 200 may be included in/or on anophthalmic device 250, which may also comprise a polymeric biocompatiblematerial. The ophthalmic device 250 may include a rigid center, softskirt design wherein a central rigid optical element comprises the mediainsert 200. In some specific embodiments, the media insert 200 may be indirect contact with the atmosphere and/or the corneal surface onrespective anterior and posterior surfaces, or alternatively, the mediainsert 200 may be encapsulated in the ophthalmic device 250. Theperiphery 255 of the ophthalmic device 250 may be a soft skirt material,including, for example, a hydrogel material. The infrastructure of themedia insert 200 and the ophthalmic device 250 can provide anenvironment to monitor the retinal microvascularization according toaspects of the present invention. In addition, in the present exemplaryophthalmic device 250, micro-acoustic elements may be placed insider oron a surface of the media insert 200 to transmit audible signals throughbone resonance through the skull and to the cochlea. In someembodiments, the audible signals transmitted to the user using themicro-acoustic elements may be transmitted, for example, when thecardiac rhythm is determined to be outside a predetermined thresholdbased on monitored changes of the retinal vascularization. For example,the audible signal may be a recommended action and/or warning based oncardiac rhythm or an abnormal condition.

Referring now to FIG. 3, a diagrammatic representation of anotherexemplary energized ophthalmic device comprising both optics and theretinal vascularization monitoring system is depicted. In particular, athree dimensional cross section representation of an exemplaryophthalmic device 300 including a functionalized layer media insert 320configured to include the retinal vascularization monitoring system onone or more of its layers 330, 331, 332 is illustrated. In the presentexemplary embodiment, the media insert 320 can surround the entireperiphery of the ophthalmic device 300. One skilled in the art canunderstand that the actual media insert 320 may comprise a full annularring or other shapes that still may reside inside or on the hydrogelportion of the ophthalmic device 300 and be within the size and geometryconstraints presented by the ophthalmic environment of the user.

Layers 330, 331 and 332 are meant to illustrate three of numerous layersthat may be found in a media insert 320 formed as a stack of functionallayers. In some embodiments, for example, a single layer may include oneor more of: active and passive components and portions with structural,electrical or physical properties conducive to a particular purposeincluding the communication system functions described in the presentdisclosure. Furthermore, in some embodiments, a layer 330 may include anenergy source, such as, one or more of: a battery, a capacitor and areceiver within the layer 330. Item 331 then, in a non-limitingexemplary sense may comprise microcircuitry in a layer that detectsactuation signals for the ophthalmic device 300. In some embodiments, apower regulation layer 332, may be included that is capable of receivingpower from external sources, charges the battery layer 330 and controlsthe use of battery power from layer 330 when the ophthalmic device 300is not in a charging environment. The power regulation may also controlsignals to an exemplary active lens, demonstrated as item 310 in thecenter annular cutout of the media insert 320.

An energized ophthalmic device 300 with an embedded media insert 320 mayinclude an energy source, such as an electrochemical cell or battery(lithium ion cell) as the storage means for the energy and in someembodiments, encapsulation, and isolation of the materials comprisingthe energy source from an environment into which an ophthalmic device300 is placed. In some embodiments, a media insert 320 can also includea pattern of circuitry, components, and energy sources. Variousembodiments may include the media insert 320 locating the pattern ofcircuitry, components and energy sources around a periphery of an opticzone through which a wearer of an ophthalmic lens would see, while otherembodiments may include a pattern of circuitry, components and energysources which are small enough to not adversely affect the sight of theophthalmic lens wearer and therefore the media insert 320 may locatethem within, or exterior to, an optical zone without consequence.

Reference has been made to electronic circuits making up part of thecomponentry of ophthalmic devices incorporating a retinalvascularization monitoring system. In some embodiments according toaspects of the disclosure, a single and/or multiple discrete electronicdevices may be included as discrete chips, for example, in theophthalmic media inserts. In other embodiments, the energized electronicelements can be included in the media insert in the form of stackedintegrated components. Accordingly and referring now to FIG. 4, aschematic diagram of an exemplary cross section of a stacked dieintegrated components implementing the retinal vascularizationmonitoring system 410 is depicted. In particular, the media insert mayinclude numerous layers of different types which are encapsulated intocontours consistent with the ophthalmic environment that they willoccupy. In some embodiments, these media inserts with stacked integratedcomponent layers may assume the entire annular shape of the mediainsert. Alternatively in some cases, the media insert may be an annuluswhereas the stacked integrated components may occupy just a portion ofthe volume within the entire shape.

As shown in FIG. 4, there may be thin film batteries 430 used to provideenergization. In some embodiments, these thin film batteries 430 maycomprise one or more of the layers that can be stacked upon each otherwith multiple components in the layers and interconnectionstherebetween.

In some embodiments, there may be additional interconnections betweentwo layers that are stacked upon each other. In the state of the artthere may be numerous manners to make these interconnections; however,as demonstrated the interconnection may be made through solder ballinterconnections between the layers. In some embodiments only theseconnections may be required; however, in other cases the solder ballsmay contact other interconnection elements, as for example with acomponent having through layer vias.

In other layers of the stacked integrated component media insert, alayer 425 may be dedicated for the interconnections two or more of thevarious components in the interconnect layers. The interconnect layer425 may contain, vias and routing lines that can pass signals fromvarious components to others. For example, interconnect layer 425 mayprovide the various battery elements connections to a power managementunit 420 that may be present in a technology layer 415. Other componentsin the technology layer 415 can include, for example, a transceiver 445,control components 450 and the like. In addition, the interconnect layer425 may function to make connections between components in thetechnology layer 415 as well as components outside the technology layer415; as may exist for example in the integrated passive device 455.There may be numerous manners for routing of electrical signals that maybe supported by the presence of dedicated interconnect layers such asinterconnect layer 425.

In some embodiments, the technology layer 415, like other layercomponents, may be included as multiple layers as these featuresrepresent a diversity of technology options that may be included inmedia inserts. In some embodiments, one of the layers may include CMOS,BiCMOS, Bipolar, or memory based technologies whereas the other layermay include a different technology. Alternatively, the two layers mayrepresent different technology families within a same overall family; asfor example one layer may include electronic elements produced using a0.5 micron CMOS technology and another layer may include elementsproduced using a 20 nanometer CMOS technology. It may be apparent thatmany other combinations of various electronic technology types would beconsistent within the art described herein.

In some embodiments, the media insert may include locations forelectrical interconnections to components outside the insert. In otherexamples, however, the media insert may also include an interconnectionto external components in a wireless manner. In such cases, the use ofantennas in an antenna layer 435 may provide exemplary manners ofwireless communication. In many cases, such an antenna layer 435 may belocated, for example, on the top or bottom of the stacked integratedcomponent device within the media insert.

In some of the embodiments discussed herein, the battery elements 430may be included as elements in at least one of the stacked layersthemselves. It may be noted as well that other embodiments may bepossible where the battery elements 430 are located externally to thestacked integrated component layers. Still further diversity inembodiments may derive from the fact that a separate battery or otherenergization component may also exist within the media insert, oralternatively these separate energization components may also be locatedexternally to the media insert.

Components of the retinal vascularization monitoring system 410 may alsobe included in a stacked integrated component architecture. In someembodiments, the retinal vascularization monitoring system 410components may be attached as a portion of a layer. In otherembodiments, the entire retinal vascularization monitoring system 410may also comprise a similarly shaped component as the other stackedintegrated components.

Referring now to FIG. 5 is a schematic diagram of a processor that maybe used to implement some aspects of the present disclosure isillustrated. The controller 500 can include one or more processors 510,which may include one or more processor components coupled to acommunication device 520. In some embodiments, a controller 500 can beused to transmit energy to the energy source placed in the ophthalmicdevice.

The processors 510 can be coupled to a communication device configuredto communicate energy via a communication channel. The communicationdevice may be used to electronically communicate with components withinthe media insert, for example. The communication device 520 may also beused to communicate, for example, with one or more controller apparatusor programming/interface device components.

The processor 510 is also in communication with a storage device 530.The storage device 530 may comprise any appropriate information storagedevice, including combinations of magnetic storage devices, opticalstorage devices, and/or semiconductor memory devices such as RandomAccess Memory (RAM) devices and Read Only Memory (ROM) devices.

The storage device 530 can store a program 540 for controlling theprocessor 510. The processor 510 performs instructions of a softwareprogram 540, and thereby operates in accordance with the presentinvention. For example, the processor 510 may receive informationdescriptive of media insert placement, active target zones of theretinal vascularization, component placement, imaging resolution and/orfrequency, and the like. The storage device 530 can also store otherpre-determined ophthalmic related data in one or more databases 550 and560. The database may include, for example, predetermined retinal zonesexhibiting changes according to cardiac rhythm or an abnormal conditioncorrelated with the retinal vascularization, measurement thresholds,metrology data, and specific control sequences for the system, flow ofenergy to and from a media insert, communication protocols, and thelike. The database may also include parameters and controllingalgorithms for the control of the retinal vascularization monitoringsystem that may reside in the ophthalmic device as well as data and/orfeedback that can result from their action. In some embodiments, thatdata may be ultimately communicated to/from an external receptionwireless device.

Referring now to FIG. 6A, a representation of a region of the retinalvascularization of an eye is depicted. In particular, a series ofvessels forming part of the retinal vascularization 600 are shown asthey would be viewed from the anterior portion of the eye by theultrasound imaging system. In the present exemplary representation, thevessels branch off each other forming a dense pattern that can be usefulto study the vessel tortuosity, the angle and number of bifurcations,and the length to width ratio. Monitoring temporal changes of thevessels or their overall structures can be useful to predict risk tocardiac conditions including, for example, microvascular disease ordiabetes, and cardiac rhythm.

Referring now to FIG. 6B, the region of the retinal vascularization ofan eye of FIG. 6A is illustrated with a digital overlay useful for theanalysis of changes of the retinal vascularization. In particular, theexemplary overlay can be useful to divide the observed region of theretinal vascularization into concentric grid sections that can be usedfor filtering and/or image segmentation. In some embodiments, gridsections may take other forms such including line patterns and the like.Concentric grid sections however may be preferred for filtering andimage segmentation due to the arcuate shape of the cornea conforming tothe spherical shape of the eye. When eye movement or flickering preventsprocessing of the different segmented portions, image processingtechniques that include edge recognition can be used to connect thedifferent segments allowing for the analysis of the portion of theretinal vascularization being monitored.

In the present example, changes of each vessel may be identified inrelation to each of the particular concentric regions A, B, or C. Byfocusing the image analysis to a specific portion/region, the amount ofimage processing and analysis can be reduced thereby lowering power andprocessing requirements. For example, the frequency in which each of theregions is imaged can be alternated depending on the changes in pulsedetected. In another scenario, only a first region that includes asegment of a pulsating vessel may be monitored until a change that fallsoutside a predetermined threshold is detected. Average changes in vesseldiameter during the cardiac cycle may be approximately 1.2 μm forarteries and 1.6 μm for veins. Accordingly, a signal may be outputtedonce a change in diameter of an identified artery is less than 0.8 μmand greater than 1.6 μm over a short period of time. Similarly, a changein the diameter of a vein that is less than 1.2 μm or greater than 2.0μm may trigger a signal. The signal may activate additional sensors,increase the rate of image capture, record the abnormality, and/or senda message to the user. The message can be sent to the user via an audiosignal and/or a visual signal provided by the ophthalmic device itselfor a device in wireless communication with the ophthalmic device.

Referring back to the present example shown in FIG. 6B, the width ordiameter of a vessel may be monitored at point 605. Point 605 may havebeen identified as a positive pulsating point of reference during aninitial retinal examination using high definition imaging techniqueincluding mydriatic and/or nonmydriatic retinal screenings. When anabnormal change in diameter or rate of pulsations is initially detected,point of reference 605 can be analyzed in conjunction with point ofreference 610 pointing to the same vessel. Analysis at both points ofreference may be used to provide the system with more measurements forthe determination of blood pressure, for example. In some embodiments,other reference points on pulsating/non-pulsating vessels in a differentregion may also be monitored, simultaneously or in alternating modes, toensure that the change is uniform throughout the vascularization. Forexample, at additional point of reference 615 in region C.

Referring now to FIG. 7, a side cross section representation of apatient's eye with an exemplary energized ophthalmic device isillustrated. In particular, an ophthalmic device 700 taking form of anenergized contact lens is illustrated resting on the cornea 706 withocular fluid in at least some portions between the ophthalmic device 700and the cornea 706. In some embodiments, the concave contour of theophthalmic device 700 may be designed so that one or more piezoelectrictransducers can rest directly on the cornea 706. Having thepiezoelectric transducers resting directly on the cornea 706 can allowgreater imaging detail as the ultrasonic pulses can travel directlytowards the cornea 706 from focal points 702, 710. In alternativeembodiments, only one or more than two focal points/piezoelectrictransducers may be implemented. As depicted in the present exemplaryembodiment, the piezoelectric transducer(s) are located on the peripheryarea of the energized contact lens and outside of the line of sight toprevent vision interference. However, in alternative energized contactlens devices the piezoelectric transducer may be located in the centerregion located in front of the pupil 704 also without significantlyinterfering with the vision of a user.

Accordingly, depending on the design of the ophthalmic device 700 theultrasonic pulses may pass through the eye's lens 708 before passingthrough the vitreous humour 720 and reaching one or more retinal areasincluding pulsating vessels, e.g. 712 and 716. In some embodiments, theretinal areas may be pre-determined areas near or that include ocularparts serving a specific function or that can be used as a predictor ofa particular condition including, for example, the macula 714 which maybe screened for the early detection of peripheral vision loss.

Referring now to FIG. 8, method steps that can be implemented by thesystem according to aspects of the present disclosure are illustrated ina flowchart. Beginning at step 801, regions/zones with retinalvascularization can be identified for imaging. According to someaspects, the retinal vascularization in the identified region/zoneincludes portions of one or more pulsating vessels. These regions/zonescan be identified using imaging systems that are capable of reproducinghigh definition images of the microvascularization in the retina.Imaging systems may include non-invasive OCT systems, or any otherhighly reliable mydriatic or nonmydriatic diagnostic imaging method usedfor geometrical measurements of retinal structures. Depth, shape,relative position, and structure of the vascularization may bepre-programmed into the ophthalmic device in order to lowerprocessing/energy consumption requirements and reliably identify thetarget points in the areas monitored. In preferred embodiments, targetpoints can be easily identifiable image features, such as, edges,crossing, or line boundaries of vessels.

At step 805, an ophthalmic device including a retinal vascularizationmonitoring system is provided to a patient. In some embodiments, theophthalmic device may include one or two energized contact lensesconfigured to include a piezoelectric transducer with a feedback circuitused to provide an ultrasound pulse used to image themicrovascularization of an eye. The energized contact lenses canadditionally be capable of providing other functions including providingvision correction and/or enhancement via physical characteristics,wireless communication with other devices, and emitting visual and/orauditory signals to the user. The design of the ophthalmic device and,in particular, the location of the piezo-electric transducer formingpart of the retinal vascularization monitoring system may be determinedaccording to the identified region/zone of interest. In some embodimentshowever, guidelines for the imaging system to focus on the identifiedregion/zone(s) may be programmed after the design of the ophthalmicdevice.

At step 810, the retinal vascularization monitoring system can monitorone or more pre-identified target points over pre-determined periods oftime. Monitoring can include determining the cardiac rhythm from therate of pulsations of a vessel over a particular period of time 815and/or the displacement/changes of vessel(s) 820 over time. Themonitoring may be triggered, for example, based on a timer function,blink actuation, or upon receiving a signal from a wireless device incommunication with the ophthalmic device. In some embodiments, thewireless may serve as a user interface and may be a drug pump,smartphone, personal computer, tablet, and the such. Transmission ofinformation with the wireless device can occur, for example, via a RFfrequency, a local area network (LAN), and/or a private area network(PAN), depending on the communication device and functionalityimplemented by the ophthalmic device.

At steps 825 and 830, an audio/visual signal alert may be sent to theuser when either the determined cardiac rhythm and/or determined rate ofvascular displacement are outside a predetermined threshold. Forexample, a signal may be outputted when the system detects that thecardiac rhythm has increased/decreased to a hazardous level. The signalmay be sent using a wireless device in communication with the ophthalmicdevice and/or through an audible signal using micro-acoustic elementsincluded in the ophthalmic device. In some embodiments, the signal maybe a visual signal using micro-photonic elements that may also beincluded in the ophthalmic device. The audible signal may be played inconjunction with a visual signal, e.g., as part of a video clip withsafety instructions to reduce the risk of a fatal heart condition.

One or more of steps 835, 840, and 845 may occur depending on theparticular embodiment implemented. Optionally at step 835, an actuationsignal may be sent to a drug delivery apparatus to deliver a drug/activeagent. The drug delivery mechanism may include, for example, a drug pumpin wireless communication with the ophthalmic device. Optionally at step640, the signal may be correlated with a specific event imputed by thepatient using the wireless device as a user interface. For example,through a selection from a menu listing activities that can influencecardiac rhythm or blood pressure.

Also optionally, at step 845, the action and/or feedback from steps810-840 can be recorded to improve future analysis, keep a medicalrecord that can be accessed by an eye care practitioner, and/or tailorthe retinal vascularization monitoring system to the particular patient.In some embodiments, these recorded actions/records can also besent/stored using the wireless device.

The many features and advantages of the invention are apparent from thedetailed specification, and thus, it is intended by the appended claimsto cover all such features and advantages of the invention which fallwithin the true spirit and scope of the invention. Further, becausenumerous modifications and variations will readily occur to thoseskilled in the art, it is not desired to limit the invention to theexact construction and operation illustrated and described, andaccordingly, all suitable modifications and equivalents may be resortedto, falling within the scope of the invention.

1. An energized ophthalmic device with a retinal vascularizationmonitoring system, the ophthalmic device comprising: a media insertcomprising a front curve arcuate surface and a back curve arcuatesurface, wherein the front curve arcuate surface and the back curvearcuate surface form a cavity capable of containing an energy sourcedimensioned to conform to an area within the cavity, wherein the energysource is in electrical connection and capable of energizing amicro-piezoelectric element with an electronic feedback circuit and acontroller, the controller comprising a computer processor in digitalcommunication with a digital media storage device and wherein thedigital media storage device stores software code; a transmitter inlogical communication with the processor and also in logicalcommunication with a communication network, wherein the software isexecutable upon demand and operative with the processor to: receive datadescriptive of at least one identified portion of a pulsating vesselforming part of a retinal vascularization of an eye; cause themicro-piezoelectric element to output a signal towards the at least oneidentified portion of the pulsating vessel; receive data from theelectronic feedback circuit descriptive of the change of the outputtedsignal outputted towards the at least one identified portion of thepulsating vessel; image the at least one identified portion of thepulsating vessel using the data received from the electronic feedbackcircuit; and monitor changes of the retinal vascularization by comparingsaid at least one identified portion imaged with a previous image overtime.
 2. The ophthalmic device of claim 1, additionally comprising: aradio frequency antenna in connection with the communication network andcapable of transmitting data with a wireless device.
 3. The ophthalmicdevice of claim 2, wherein the monitoring of the retinal vascularizationincludes determining the cardiac rhythm by analyzing changes in diameterof the at least one identified portion over the vessel over time.
 4. Theophthalmic device of claim 3, wherein the software is additionallyoperative with the processor to: send a signal to the wireless devicewhen the determined cardiac rhythm is outside a predetermined threshold.5. The ophthalmic device of claim 3, additionally comprising: a photonemitter element in connection with the communication network and capableof providing a visual signal to the user when the determined cardiacrhythm is outside a predetermined threshold.
 6. The ophthalmic device ofclaim 3, additionally comprising: a micro-electromechanical transducercapable of transmitting an audible signal to the user when thedetermined cardiac rhythm is outside a predetermined threshold.
 7. Theophthalmic device of claim 3, wherein the software is operative with theprocessor to: transmit, through the radio frequency antenna, to a drugdispensing device a signal to dispense an active agent when thedetermined cardiac rhythm is outside a predetermined threshold.
 8. Theophthalmic device of claim 2, wherein the monitoring of the retinalvascularization includes tracking the displacement over time of the atleast one identified portion of a vessel.
 9. The ophthalmic device ofclaim 1, additionally comprising a microsensor in connection with aprocessor, wherein the microsensor is used to capture sound frequenciesarising from one or more pulsating vessels of the retina.
 10. Theophthalmic device of claim 3, wherein the software is additionallyoperative with the processor to: correlate a change of cardiac rhythmwith an associated event detected by the wireless device.
 11. Theophthalmic device of claim 10, wherein the software is operative withthe processor to: record one or both of an action or a feedback when themonitored cardiac rhythm falls outside a pre-determined range.
 12. Theophthalmic device of claim 1, wherein the energy source is fabricatedusing stacked integrated component device packaging technologies.
 13. Amethod of monitoring the retinal vascularization of a patient's eye, themethod comprising: identifying at least one location of a pulsatingvessel in the retinal vascularization of an eye; providing an ophthalmicdevice with a retinal vascularization monitoring system comprising anenergy source in electrical connection and capable of energizing amicro-piezoelectric element with an electronic feedback circuit and acontroller comprising a computer processor, a digital media storagedevice, a transmitter in logical communication with the processor andalso in logical communication with a communication network; outputting asignal towards the at least one pulsating location identified using themicro-piezoelectric element with the electronic feedback circuit;receiving, using the feedback circuit, a return signal from theoutputted signal; imaging the at least one pulsating location using thechange in the outputted signal and the return signal; and monitoringchanges of the retinal vascularization by comparing said at least oneidentified portion images with a previous image of the same said atleast one identified portion over time.
 14. The method of claim 13,wherein the monitoring changes of the retinal vascularization includerecording the changes in the diameter of the pulsating vessel over time.15. The method of claim 14, additionally comprising: determining thecardiac rhythm of a patient using the recorded changes in the diameterof the pulsating vessel over time.
 16. The method of claim 15,additionally comprising: sending a signal alert to the user of theophthalmic device when the determined cardiac rhythm falls outside apre-determined range.
 17. The method of claim 16, wherein one or boththe action of sending a signal alert to the user and the determinedcardiac rhythm is recorded as part of a patient's medical history. 18.The method of claim 13, wherein the monitoring changes of the retinalvascularization include looking at the rate of displacement of thepulsating vessel.
 19. The method of claim 18, additionally comprising:sending a signal alert to the user of the ophthalmic device when therate of displacement of the pulsating vessel falls outside apre-determined range.
 20. A method of monitoring the retinalvascularization of a patient's eye, the method comprising: identifyinglocations forming part of the retinal vascularization of the patient'seye including at least a portion of a pulsating vessel; providing anophthalmic device with a retinal vascularization monitoring systemcomprising an energy source in electrical connection and capable ofenergizing a micro-piezoelectric element with an electronic feedbackcircuit and a controller comprising a computer processor, a digitalmedia storage device, a transmitter in logical communication with theprocessor and also in logical communication with a communicationnetwork; detecting a change in a controlled signal outputted towards theat least said portion of the pulsating vessel identified; imaging the atleast said portion of the retinal vascularization of the patient's eyeusing the detected change in said controlled signal; and recording thechanges in the at least said portion of the retinal vascularizationbetween a series of images over time.